Open-Label Study of IKT-001 in Pulmonary Arterial Hypertension (PAH)

Starting soon · Phase 3

Conditions studied: Pulmonary Arterial Hypertension (PAH)

In brief

This is a multicenter, open-label extension (OLE), single-arm study designed to assess the long-term safety and tolerability of oral IKT-001 administered once daily.

Key facts

Study ID

NCT07632898

Run by

Inhibikase Therapeutics

People needed

484

Starts

2026-10-23

Expected to finish

2030-12-30

Last updated by the study team

2026-06-08

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Capable of giving signed informed consent.
• Participants who have completed Study IKT-001-201 or any other Phase 2 or 3 controlled clinical study with IKT-001.

You may not qualify if…

• Any of the following clinical laboratory values at screening:
• ALT or AST levels >3× the ULN
• Bilirubin levels >2× the ULN
• ANC <1.2 ×10\^9 cells/L, hemoglobin <9 g/dL, hematocrit <30%, or platelets <75 × 10\^9 cells/L
• Absolute eGFR <30 mL/min using creatinine or cystatin C as defined by the CKD-EPI equation (2021)
• Currently lactating, pregnant or planning on becoming pregnant during the study.
• Receiving treatment with sotatercept.

Full record on ClinicalTrials.gov

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